Breathing-controlled inhalation device for dry powders

ABSTRACT

The invention relates to a breathing-controlled inhalation device for dry powders, having an air guide unit consisting of an essentially cylindrical body, said air guide unit comprising a flow passage provided alternately with constrictions and in each instance following enlargements, said constrictions and enlargements passing continuously one into another, and the flow passage for the air flowing through the air guide unit being of three-dimensional meander-like conformation.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. national stage application ofInternational Patent Application No. PCT/DE01/04377, filed Nov. 22,2001, published in German on Jun. 12, 2003 as PCT Publication No.WO03/047670, incorporated herein in its entirety. This applicationclaims priority from the International Application pursuant to 35 U.S.C.§ 365.

BACKGROUND OF THE INVENTION

Inhalation as a gentle therapeutic method is of great importance today,primarily in the field of disorders of the respiratory passages, or forsimple and fast-acting administration of medicinal drugs. A dry powdertreated with medicinal drugs may be supplied to the patient'srespiratory passages as a fine mist. The method of delivery duringinhalation requires a complete and uniform distribution of the drypowder that is uncomplicated and rapid.

German Patent Application 199 48 289.6 discloses an apparatus that makespossible such a distribution of the dry powder by the flow-controllingstructure of a simple cylindrical body in a special inhalation housing.The air guide unit disclosed is in the form of a cylindrical body,surrounded by a housing, and is not flexibly replaceable. The dry powdermust be fed to a special supply chamber, before its delivery to the airguide unit. To guarantee exact dosage of the dry powder and to ensurethat the dry powder does not pick up any moisture, considerabletechnical outlay is required of the user.

U.S. Pat. No. 5,562,918 discloses a dispenser system for the inhalationof powdered medicinal drugs by suction using respiratory air. Thisdispenser consists of several parts, specifically a cylindrical mainbody comprising closures openable by action of axial force and isprovided with an intake opening and an air inlet. To achieve an adequateturbulence of the air drawn in by the dispenser, a turbine is providedin the air inlet. In the nozzle, a grid is further provided, to preventintake of larger particles.

The dispenser disclosed in U.S. Pat. No. 5,562,918 exhibits acomplicated structure, rendering it costly to produce and complicated touse. The dispenser is limited in that two or more dispensers cannot beconnected to each other magazine-fashion. Although it is a prerequisitefor inhalation of all powder uniformly distributed in the air, theadequate turbulence of the air taken in by the dispenser is not to beexpected through the use of the disclosed dispenser.

WO A 96/22802 shows an inhaler comprising a tubular body to define anair passage, provided with closure caps and filled with a powder. Theair passage may be rectangular, square, polygonal, elliptical orcircular in cross-section, the cross-sectional area being smaller at thenozzle than at the opposed end. In addition, flexible segments areprovided to permit adaptation to anatomical givens. In order to improvethe distribution of the particles being inhaled, the inhaler may beprovided with means to generate a rotation of the air. Such means maycomprise spiraled depressions or ribs on the inner wall of the tubularbody. This inhaler, in the simplest embodiment, is of very simplestructure, but fails to achieve an adequate turbulence of the air.

An inhalation device for delivery of dry powders must be simple to useand readily available at a moment's notice. Therefore, there is a needto minimize problems by simplifying the technical structure of theinhalation device.

The object of the invention, then, is to create an inhalation deviceaffording access in a matter of seconds by immediate readiness for use,and by a structural reduction of the elements of the device, limiting toa minimum the operating moves of the patient before, during and afterthe inhalation, and likewise structurally ruling out virtually any riskof trouble.

SUMMARY OF THE INVENTION

The invention relates to a breathing-controlled inhalation device fordry powders, having an air guide unit consisting of an essentiallycylindrical body, said air guide unit comprising a flow passage providedalternately with constrictions and in each instance followingenlargements, said constrictions and enlargements passing continuouslyone into another, and the flow passage for the air flowing through theair guide unit being of three-dimensional meander-like conformation.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The invention may be better understood by reference to one ormore of these drawings in combination with the detailed description ofspecific embodiments presented herein:

FIG. 1 shows the inhalation device in a possible magazine arrangement,and

FIG. 2 shows an individual air guide unit in the form of a cylindricalbody.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to a breathing-controlled inhalation device fordry powders, having an air guide unit consisting of an essentiallycylindrical body, said air guide unit comprising a flow passage providedalternately with constrictions and in each instance followingenlargements, said constrictions and enlargements passing continuouslyone into another, and the flow passage for the air flowing through theair guide unit being of three-dimensional meander-like conformation.

The inhalation device of the present invention comprises a magazine ofone-piece bodies of cylindrical configuration as air guide unit, eachbody being provided with an air inlet and an intake opening oriented inlike direction and each sealed in transport condition with anauthenticity closure, the bodies being directly or indirectlyinterconnected by way of a plurality of weak spots, and the bodies beingfilled with a rationed quantity of dry powder.

The presently claimed device provides an extremely economical andimmediately available apparatus placed at the patient's disposal. Thepatient may inhale rationed active agents at need without being exposedto any risk of trouble with the inhalation device. First of all, theactive agent is already contained in the magazined air guide units,readily detachable from each other. Secondly, the inhalation deviceitself has been technically minimized. The device according to thepresent invention dispenses entirely with movable parts. Therefore, thepresently claimed device can be produced very economically and treatedas a disposable item. In addition, the penetration of moisture issecurely prevented.

The sealing of the inhalation device with authenticity closures ensuresthat always only the predetermined quantity of the active agent alreadypresent in the air guide unit, namely dry powder, is available.

In an embodiment of the invention, the authenticity closures can beseparated without problems at prestamped weak spots. As used herein,weak spots are junctures at which various parts of the inhalation deviceare connected. The weak spots may be indentations or perforations in thematerial that form the inhalation device.

In one embodiment of the invention, the authenticity closure is fixedlyconnected to a flat geometrical grip part. The grip part is convenientfor detaching the authenticity closure.

An another embodiment of the invention, the air inlet and the intakeopening, lying in a recess of corresponding outline in the current grippart, are connected to the current grip part by way of weak spots. Thegrip parts are arranged in the plane of symmetry of the magazine andweak spots are provided between the current grip parts and thecylindrical bodies.

The grip parts perform the function of a geometrically symmetricalbinding element between the several cylindrical bodies, directly orindirectly connected by way of weak spots. In addition, they stabilizethe integrity of the authenticity closures.

By virtue of the weak spots provided in the manner specified, thecylindrical bodies can be first separated from each other, and then theintake opening and the air inlet completely freed from the grip parts.

In another embodiment of the invention, the cylindrical bodies arearranged in pairs inside the magazine, the cylindrical bodies within apair being connected to each other by way of weak spots at the outeredges of the grip parts of the air inlet. These pairs may in turn beinterconnected by weak spots at each of the outer edges of thecylindrical bodies opposed to the grip parts of the air inlet. Thearrangement here chosen for the cylindrical bodies within the magazinerepresents an especially favorable variant connection, distinguished bya high stability and conducive, within the process of manufacture, tofilling up the cylindrical bodies with the dry powder and to thesubsequent steps of connection and sealing. Other variants ofarrangement are conceivable.

In a preferred embodiment of the invention, the weak spots forseparating the authenticity closure at the air inlet are stronger thanthe weak spots between air inlet and grip part and the weak spotsbetween grip part and cylindrical body. In addition, the weak spots forseparating the authenticity closure at the intake opening is strongerthan the weak spots between intake opening and grip part and the weakspots between grip part and cylindrical body. This ensures that theauthenticity closure will not be opened inadvertently.

In another embodiment of the invention, the weak spots between the grippart and the cylindrical body is stronger than the weak spots at theouter edge of the grip part and the weak spots at the outer edge of thecylindrical body opposed to the grip part of the air inlet. Thisprevents a partial or complete detachment of the grip part from thecylindrical body upon release of only a single air guide unit from themagazine, thus endangering the stabilization of the authenticity closureby the grip part.

The invention will be further illustrated below in terms of anembodiment by way of example referred to in FIGS. 1 and 2 and is in nomanner limited by the provided example. Reference to numerals in FIGS. 1and 2 is provided in Table 1 below. TABLE 1 List of Reference Numeralsand their corresponding descriptions  1 cylindrical body  1a upperspherical segment-like depressions  1b lower spherical segment-likedepressions  2 air inlet  3 intake opening  4a upper grip part  4b lowergrip part  5a upper authenticity closure  5b lower authenticity closure 6a intake opening weak spots  6b air inlet weak spots  7a upperauthenticity closure weak spots  7b lower authenticity closure weakspots  8 lower external grip part weak spots  9 cylindrical body weakspots 10 horizontal cylindrical body weak spots 11 lower internal grippart weak spots

The inhalation device according to the invention consists of a pluralityof cylindrical bodies (1) connected to form a chain in magazine fashion.These cylindrical bodies (1) are provided as air guide units, comprisinga flow passage provided alternately with constrictions and in eachinstance following enlargements, said constrictions and enlargementspassing continuously one into another, and the flow passage for the airflowing through the air guide unit having a three-dimensionalmeander-like conformation. The cylindrical body (1) is provided for thispurpose with spherical depressions (1 a) and (1 b), extending frommutually opposed walls of the cylindrical body (1) into the flowpassage.

The patient can at need take from the magazine a single air guide unitwith a pre-portioned quantity of dry powder treated with medicinaldrugs, or a medicinal drug in the form of dry powder. The individual airguide units in the form of the cylindrical bodies (1) are connected toeach other directly or indirectly by way of flat lower grip parts (4 b)by pre-stamped weak spots (8; lower external grip part weak spots) and(9; cylindrical body weak spots), so that the required air guide unitcan be broken out of the magazine.

As favorable to the stabilization of the device, important in transport,an arrangement has been found such that the cylindrical bodies (1) arearranged in the magazine in pairs, the cylindrical bodies (1) within apair being connected to each other at the outer edges of the lower grippart (4 b) of the air inlets (2). These pairs are in turn connected,again by weak spots (8; lower external grip part weak spots) and (9;cylindrical body weak spots), at each outer edge of the cylindrical body(1) opposed to the lower grip parts (4 b) of the air inlet (2).

The cylindrical bodies are directly or indirectly connected one toanother by way of weak spots (8; lower external grip part weak spots)and (9; cylindrical body weak spots) in that each cylindrical body isprovided with an air inlet (2) and an intake opening (3) oriented inlike direction and, in transport condition, each sealed with anauthenticity closure (5 a; upper) and (5 b; lower).

The upper and lower authenticity closures (5 a and 5 b) may be connectedto the air inlet (2) and the intake opening (3) by way of a weak spots(7 a; upper authenticity closure weak spots and 7 b; lower authenticityclosure weak spots).

The upper and lower authenticity closures (5 a and 5 b) may each befixedly connected to flat upper and lower geometrical grip parts (4 aand 4 b). The upper and lower grip parts (4 a and 4 b) may be arrangedin the plane of symmetry of the magazine.

The air inlet (2) of the device, lying in a recess of the lower grippart (4 b) matching the outline of the air inlet (2), may be connectedto the lower grip part (4 b) by way of air inlet weak spots (6 b), andfurthermore there is a connection in the form of a weak spots (11; lowerinternal grip part weak spots) between the lower grip part and thecylindrical body.

Since the weak spots (7 b; lower authenticity closure weak spots) fordetaching the lower authenticity closure (5 b) at the air inlet (2) isstronger than the weak spots (6 b; air inlet weak spots) between airinlet (2) and lower grip part (4 b) and the weak spots (11; lowerinternal grip part weak spots) between lower grip part (4 b) and thecylindrical body (1), and furthermore the weak spots (7 a; upperauthenticity closure weak spots) for detaching the upper authenticityclosure (5 a) at the intake opening (3) is stronger than the weak spots(6 a; intake opening weak spots) between intake opening (3) and uppergrip part (4 a) and the weak spots (10; horizontal cylindrical body weakspots) between the upper grip part (4 a) and cylindrical body (1), it isensured that the upper authenticity closure (5 a) is not openedinadvertently.

An inadvertent release of the lower grip part (4 b), and hence anendangerment of the stabilization of the lower authenticity closure (5b) is further prevented in that the weak spots (11; lower internal grippart weak spots) between the lower grip part (4 b) and cylindrical body(1) is stronger than the weak spots at the outer edge of the lower grippart (8; lower external grip part weak spots) and the weak spots (9;cylindrical body weak spots) at the outer edge of the cylindrical body(1) opposed to the lower grip part (4 b) of the air inlet (2).

In order to be able to inhale the quantity of dry powder contained bythe air guide unit, the upper and lower authenticity closures (5 a) and(5 b) located at an air inlet (2) and intake opening (3) and likewiseconnected to these by way of weak spots (7 a; upper authenticity closureweak spots) and (7 b; lower authenticity closure weak spots) aredetached by means of the upper and lower grip parts (4 a) and (4 b), thegrip parts being completely eliminable from the cylindrical bodies bybreaking up corresponding weak spots (6 a, 6 b, 10 and 11), and theinhalation device thereby finally put into the condition ready for use.Thereupon, the intake opening (3) of the inhalation device can bebrought to the mouth and air taken in, or inhaled. Upon intake of theair flowing in by way of the air inlet (2), the special conformation ofthe cylindrical body (1) as described results in an optimal distributionof the dry powder particles treated with the active substance, in thatthe air passing through is caused to circulate in a special manner.Since the intake opening (3) and the air inlet (2) are oriented alike,i.e. upward, and the patient when inhaling will incline his head byhardly more than 90 degrees, unintentional escape of the dry powder isnot possible.

Various references, patents, publications, product descriptions, etc.,are cited throughout this specification, the disclosures of which areincorporated herein by reference in their entireties for all purposes.

1-11. (canceled)
 12. Breathing-controlled inhalation device for drypowders, having an air guide unit consisting essentially of acylindrical body, said air guide unit comprising a flow passagealternately provided with constrictions and in each instance followingenlargements, said constrictions and enlargements passing continuouslyone into another, so that the flow passage is of three-dimensionalmeander-like conformation, wherein at least two cylindrical bodiesconnected to each other in a magazine-fashion are provided as air guideunits, the cylindrical bodies being directly or indirectly connected oneto another by way of weak spots in that each cylindrical body isprovided with an air inlet and an intake opening oriented in likedirection and, in transport condition, each sealed with an authenticityclosure, wherein the intake opening is sealed with an upper authenticityclosure and the an air inlet is sealed with a lower authenticityclosure, and wherein the cylindrical bodies are filled with a rationedquantity of dry powder.
 13. The breathing-controlled inhalation deviceaccording to claim 12, wherein the lower authenticity closure isconnected to the air inlet by way of lower authenticity closure weakspots and the upper authenticity closure is connected to the intakeopening by way of upper authenticity closure weak spots.
 14. Thebreathing-controlled inhalation device according to claim 12, whereinthe upper authenticity closure is fixedly connected to a flatgeometrical upper grip part and the lower authenticity closure isfixedly connected to a flat geometrical lower grip part.
 15. Thebreathing-controlled inhalation device according to claim 14, whereinthe upper and lower grip parts are arranged in the plane of symmetry ofthe magazine.
 16. The breathing-controlled inhalation device accordingto claim 14, wherein the air inlet, lying in a recess of the lower grippart matching the outline of the air inlet, is connected to the lowergrip part by way of air inlet weak spots, and the lower grip part isconnected to the cylindrical body by lower internal grip part weakspots.
 17. The breathing-controlled inhalation device according to claim15, wherein the air inlet, lying in a recess of the lower grip partmatching the outline of the air inlet, is connected to the lower grippart by way of air inlet weak spots, and the lower grip part isconnected to the cylindrical body by lower internal grip part weakspots.
 18. The breathing-controlled inhalation device according to claim14, wherein the intake opening, lying in a recess of the upper grip partmatching the outline of the intake opening, is connected to the uppergrip part by way of intake opening weak spots, and the upper grip partis connected to the cylindrical body by horizontal cylindrical body weakspots.
 19. The breathing-controlled inhalation device according to claim15, wherein the intake opening, lying in a recess of the upper grip partmatching the outline of the intake opening, is connected to the uppergrip part by way of intake opening weak spots, and the upper grip partis connected to the cylindrical body by horizontal cylindrical body weakspots.
 20. The breathing-controlled inhalation device according to claim14, wherein the cylindrical bodies are arranged in pairs within themagazine, the cylindrical bodies being connected to each other by way oflower external grip part weak spots found at the outer edges of thelower grip part of the air inlets.
 21. The breathing-controlledinhalation device according to claim 15, wherein the cylindrical bodiesare arranged in pairs within the magazine, the cylindrical bodies beingconnected to each other by way of lower external grip part weak spotsfound at the outer edges of the lower grip part of the air inlets 22.The breathing-controlled inhalation device according to claim 20 or 21,wherein the pairs are connected to each other in each instance by way ofcylindrical body weak spots found at the outer edges of the cylindricalbodies opposed to the lower grip parts of the air inlet.
 23. Thebreathing-controlled inhalation device according to claim 21, whereinthe pairs are connected to each other in each instance by way ofcylindrical body weak spots found at the outer edges of the cylindricalbodies opposed to the lower grip parts of the air inlet.
 24. Thebreathing-controlled inhalation device according to claim 16, whereinhorizontal lower authenticity closure weak spots for detaching the lowerauthenticity closure at the air inlet is stronger than (1) the lowerinternal grip part weak spots located between air inlet and lower grippart and (2) lower internal grip part weak spots found between the lowergrip part and cylindrical body.
 25. The breathing-controlled inhalationdevice according to claim 17, wherein horizontal lower authenticityclosure weak spots for detaching the lower authenticity closure at theair inlet is stronger than (1) the lower internal grip part weak spotslocated between air inlet and lower grip part and (2) lower internalgrip part weak spots found between the lower grip part and cylindricalbody.
 26. The breathing-controlled inhalation device according to claim18, wherein upper authenticity closure weak spots for detaching theupper authenticity closure at the intake opening is stronger than (1)intake opening weak spots found between intake opening and upper grippart and (2) horizontal cylindrical body weak spots found between theupper grip part and cylindrical body.
 27. The breathing-controlledinhalation device according to claim 19, wherein upper authenticityclosure weak spots for detaching the upper authenticity closure at theintake opening is stronger than (1) intake opening weak spots foundbetween intake opening and upper grip part and (2) horizontalcylindrical body weak spots found between the upper grip part andcylindrical body.
 28. The breathing-controlled inhalation deviceaccording to claim 24, wherein lower internal grip part weak spots foundbetween the lower grip part and cylindrical body is stronger than (1)the lower external grip part weak spots found at the outer edge of thelower grip part and (2) the cylindrical body weak spots at the outeredge of the cylindrical body opposed to the lower grip part of the airinlet.
 29. The breathing-controlled inhalation device according to claim25, wherein lower internal grip part weak spots found between the lowergrip part and cylindrical body is stronger than (1) the lower externalgrip part weak spots found at the outer edge of the lower grip part and(2) the cylindrical body weak spots at the outer edge of the cylindricalbody opposed to the lower grip part of the air inlet.
 30. Thebreathing-controlled inhalation device according to claim 26, whereinlower internal grip part weak spots found between the lower grip partand cylindrical body is stronger than (1) the lower external grip partweak spots found at the outer edge of the lower grip part and (2) thecylindrical body weak spots at the outer edge of the cylindrical bodyopposed to the lower grip part of the air inlet.
 31. Thebreathing-controlled inhalation device according to claim 27, whereinlower internal grip part weak spots found between the lower grip partand cylindrical body is stronger than (1) the lower external grip partweak spots found at the outer edge of the lower grip part and (2) thecylindrical body weak spots at the outer edge of the cylindrical bodyopposed to the lower grip part of the air inlet.